Study of MK-4166 and MK-4166 in Combination With Pembrolizumab (MK-3475) in Participants With Advanced Solid Tumors (MK-4166-001)



Status:Recruiting
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:6/16/2018
Start Date:June 27, 2014
End Date:October 17, 2019
Contact:Toll Free Number
Phone:1-888-577-8839

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Phase 1 Trial of Single Agent MK-4166 and MK-4166 in Combination With Pembrolizumab in Subjects With Advanced Malignancies

This is a 5-part dose-escalation study to determine the maximum tolerated dose (MTD)/maximum
administered dose (MAD) of MK-4166 in participants with advanced solid tumors. In Part A,
MK-4166 doses will be escalated quickly in successive cohorts and based on safety events may
progress to Part B, in which the preliminary MTD will be identified. Based on safety events
the study may progress to Part C in which the MTD will be confirmed. In Part D, participants
will receive escalating doses of MK-4166 plus a fixed dose of pembrolizumab (MK-3475) 200 mg
to determine the MTD for MK-4166 in combination with pembrolizumab. Based on safety events in
Part D, the study may progress to Part E in which the MTD for MK-4166 in combination with
pembrolizumab will be confirmed.

With Amendments 05/06, the dose confirmation Part E (combination of MK-4166 and
pembrolizumab) will be limited to participants with advanced malignant melanoma.

The primary study hypotheses are that MK-4166 as a single agent and MK-4166 in combination
with pembrolizumab have acceptable safety and tolerability.


Inclusion criteria:

- Has a histologically- or cytologically-confirmed metastatic solid tumor for which
there is no available therapy which may convey clinical benefit. Part E: Has advanced
malignant melanoma.

- Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) version
1.1

- Performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG)
Performance Scale

- Adequate organ function

- Female participants of childbearing potential must have a negative urine or serum
pregnancy test and must be surgically sterile or willing to use 2 methods of birth
control or abstain from heterosexual activity for the course of the study through 120
days after last dose of study drug

- Male participants must agree to use an adequate method of contraception during sexual
contact with females of childbearing potential starting with the first dose of study
drug through 180 days after the last dose of study drug

- Submit an evaluable tumor sample for analysis.

Exclusion criteria:

- Chemotherapy, radiation, or biological cancer therapy within 4 weeks prior to the
first dose of study drug, or who has not recovered to Common Terminology Criteria for
Adverse Events (CTCAE) Grade 1 or better from the adverse events due to cancer
therapeutics administered more than 4 weeks earlier

- Currently participating or has participated in a study of an investigational agent or
using an investigational device within 28 days of administration of MK-4166

- Expected to require any other form of antineoplastic therapy while on study

- On chronic systemic steroid therapy in excess of replacement doses, or on any other
form of immunosuppressive medication

- History of a malignancy for which potentially curative treatment has been completed,
with no evidence of malignancy for 5 years excepting successful definitive resection
of basal cell carcinoma of the skin, superficial bladder cancer, or in situ cervical
cancer

- Known active central nervous system (CNS) metastases and/or carcinomatous meningitis

- Severe hypersensitivity reaction to treatment with another monoclonal antibody

- Active autoimmune disease or a documented history of autoimmune disease, except
vitiligo or resolved childhood asthma/atopy

- Active infection requiring therapy

- Current pneumonitis, or a history of (non-infectious) pneumonitis that required
steroids

- Prior stem cell or bone marrow transplant

- Positive for human immunodeficiency virus (HIV), Hepatitis B, or Hepatitis C

- Known psychiatric or substance abuse disorders that would interfere with cooperation
with the requirements of the trial

- Regular user (including "recreational use") of any illicit drugs or recent history
(within the last year) of substance abuse (including alcohol)

- Symptomatic ascites or pleural effusion

- Pregnant, breastfeeding, or expecting to conceive or father children within the
projected duration of the study

- Clinically significant heart disease

- Major surgery in the past 16 weeks

- Received a live vaccine within 30 days prior to first dose of study drug
We found this trial at
2
sites
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mi
from
San Antonio, TX
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North Ryde, 2113
Phone: 61 2 8988 8428
?
mi
from
North Ryde,
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